Regulatory Affairs Associate

Ayati Devices; Bengaluru; Sur place; INR 400 000 - 600 000; Plein temps

Résumé du poste

Ayati Devices Pvt. Ltd. designs and manufactures screening and imaging medical devices in diabetology, neurology, cardiovascular care and podiatry.

The Regulatory Affairs Associate will prepare and maintain regulatory documentation and submissions for India (CDSCO) and international markets. Role involves preparing device master files, handling CDSCO filings, responding to queries, supporting EU MDR and FDA submissions, and maintaining ISO 13485 QMS documents and post-market surveillance

Qualifications

• Hands-on regulatory affairs experience in medical devices is required.
• Exposure to Medical Devices Rules 2017, ISO 13485 and ISO 14971 is preferred.
• Exposure to EU MDR, US FDA or ASEAN regulations is an advantage.
• Strong technical writing, attention to detail and organised document control.
• Good communication skills in English; proficiency in MS Office.

Responsabilités

• Prepare Device Master Files and Plant Master Files per MDR 2017; file and track CDSCO applications on the SUGAM portal.
• Respond to CDSCO queries and maintain licence validity, renewals and post-approval changes.
• Support EU MDR technical documentation, GSPR checklists and FDA 510(k) submissions.
• Maintain risk management files (ISO 14971) and collate test evidence (IEC 60601-1, IEC 60601-1-2, ISO 10993).
• Review labels, IFUs and UDI data for regulatory compliance.
• Support ISO 13485 QMS activities: document control, CAPA, change control and audits.
• Support post-market surveillance, complaint handling and Materiovigilance (MvPI) reporting.

Connaissances

Technical writing

Attention to detail

Document control

English communication

Outils

MS Office

Description du poste

Job Summary

Role Summary: Ayati Devices designs and manufactures screening and imaging medical devices in diabetology, neurology, cardiovascular care and podiatry. The Regulatory Affairs Associate will prepare and maintain regulatory documentation and submissions for India (CDSCO) and international markets.

Responsibilities

• Prepare Device Master Files and Plant Master Files per MDR 2017; file and track CDSCO applications on the SUGAM portal.
• Respond to CDSCO queries and maintain licence validity, renewals and post-approval changes.
• Support EU MDR technical documentation, GSPR checklists and FDA 510(k) submissions.
• Maintain risk management files (ISO 14971) and collate test evidence (IEC 60601-1, IEC 60601-1-2, ISO 10993).
• Review labels, IFUs and UDI data for regulatory compliance.
• Support ISO 13485 QMS activities: document control, CAPA, change control and audits.
• Support post-market surveillance, complaint handling and Materiovigilance (MvPI) reporting.

Requirements

• 1-2 years of hands-on regulatory affairs experience in the medical device industry.
• Working knowledge of Medical Devices Rules 2017, ISO 13485 and ISO 14971.
• Exposure to EU MDR, US FDA or ASEAN regulations is an advantage.
• Strong technical writing, attention to detail and organised document control.
• Good communication skills in English; proficiency in MS Office.

Job Details

• Job Type: Full time